New breast cancer drug! Kadcyla, a Roche targeted anticancer drug, was approved by the European Union to assist in the treatment of HER2 positive early breast cancer

December 20, 2019 / BIOON / - Roche, a Swiss pharmaceutical giant, recently announced that the European Commission (EC) has approved the HER2 targeted drug kadcyla (trastuzumab emtansine) for the treatment of HER2 positive early breast cancer with residual invasive disease in breast and / or lymph nodes after new adjuvant (preoperative) targeted therapy based on paclitane and HER2 Adjuvant (postoperative) treatment of patients with (EBC) In the United States, kadcyla was approved by the FDA in May this year for adjuvant (postoperative) treatment of HER2 positive EBC patients with residual invasive disease after new adjuvant (preoperative) treatment Previously, FDA awarded kadcyla a breakthrough drug qualification for this indication It is worth mentioning that the indication passed the real-time Oncology Review (RTOR) and assessment aid pilot program review of FDA, and it took only 12 weeks from the submission of the application to the approval Kadcyla is also the first drug approved in Roche pipeline through RTOR pilot project The project aims to explore a more effective review process to ensure that patients can access safe and effective treatment drugs as soon as possible This EU approval is based on the data of phase III clinical study Katherine This study showed that compared with Herceptin adjuvant therapy, kadcyla adjuvant therapy significantly reduced the risk of recurrence or all-cause death (IDFs) of invasive breast cancer by 50% (HR = 0.50, 95% CI: 0.39-0.64, P < 0.0001) After 3 years of treatment, 83.3% of the patients in kadcyla group had no recurrence of breast cancer, 77.0% in Herceptin group and 11.3% in absolute improvement In this study, the safety of kadcyla is consistent with the previous results The most common level 3-4 adverse events (> 1%) in kadcyla treatment group were thrombocytopenia, hypertension, radiation-induced skin injury, numbness of hands or feet, tingling or pain, neutropenia, decreased blood potassium level, fatigue and erythrocytopenia Levi Garraway, MD, Roche's chief medical officer and head of global product development, said: "early breast cancer is curable and it is important to do everything possible to prevent the disease from progressing to an incurable advanced stage in this case This kadcyla approval will provide a transformative treatment for HER2 positive early breast cancer patients in Europe who still have invasive disease after receiving new adjuvant treatment, helping to reduce the risk of disease recurrence or progression " The treatment goal of EBC is to provide patients with the best chance of cure, which may involve pre-operative and post-operative treatment as part of a comprehensive treatment Although we are close to this goal every step of the way, many patients still have relapses in the long term The purpose of new adjuvant therapy before surgery is to reduce the tumor and help improve the results of surgery The purpose of adjuvant therapy after surgery is to eliminate any residual cancer cells in the body, so as to help reduce the risk of cancer recurrence Kadcyla is one of the three innovative drugs developed by Roche for HER2 signaling pathway The other two drugs are Herceptin and perjeta The marketing of these three drugs has changed the clinical treatment mode of HER2 positive breast cancer HER2 positive breast cancer is a particularly aggressive breast cancer, affecting about 15-20% of breast cancer patients For early breast cancer (EBC), the purpose of new adjuvant (preoperative) treatment is to reduce the tumor volume so that it can be more easily removed by surgery The purpose of adjuvant (postoperative) treatment is to eliminate any residual cancer cells to reduce the risk of cancer recurrence Kadcyla is a HER2 targeted therapy, which was approved to market in 2013 Up to now, it has been approved by more than 100 countries in the world It is the first and only antibody drug conjugate (ADC) approved as a single preparation for the treatment of HER2 positive metastatic breast cancer patients who have received Herceptin and paclitaxel chemotherapy (alone or in combination) The drug is composed of trastuzumab and immunogen's cytotoxic DM1, which is delivered to HER2 positive breast cancer cells through a stable linker Kadcyla has two anticancer properties: the HER2 inhibition of trastuzumab and the cytotoxicity of DM1 Source of the original text: European Commission approves Roche's kadcyla for the adjustment treatment of people with HER2 positive early break cancer with permanent innovative release after near adjustment treatment